Medicinal Products

AMOXICILLIN QUALIMED 250 mg / 5 mL

Clamoxyl Generic Drug
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
laboratory: Mylan

Powder for oral suspension
Bottle of reconstituted suspension of 60 ml
All forms

Indication

They arise from the antibacterial activity and pharmacokinetic characteristics of amoxicillin. They take into account both the clinical studies that gave rise to this drug and its place in the range of antibacterial products currently available.

They are limited to infections due to germs defined as sensitive:

In adults and children:

· In initial treatment of:

o acute pneumonitis,

o superinfections of acute bronchitis and exacerbations of chronic bronchitis,

o ENT infections (otitis, sinusitis, documented angina at beta-hemolytic streptococcus A) and stomatology,

o urinary infections,

o male genital infections and gynecological infections,

o digestive and biliary infections,

o Lyme disease: treatment of the primary phase (chronic erythema migrans) and the primary-secondary phase (chronic erythema migrans associated with general signs: asthenia, headache, fever, arthralgia ...),

· In relay treatment of the injectable route of endocarditis, septicemia,

· As a prophylactic treatment for bacterial endocarditis.

In adults only:

· In combination with another antibiotic (clarithromycin or imidazole) and antisecretory agent, eradication of Helicobacter pylori in adult peptic ulcer disease.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AMOXICILLINE QUALIMED 250 mg / 5 mL Powder for oral suspension 60 ml reconstituted suspension bottle

One measuring spoon (5 ml) contains 250 mg of amoxicillin.

There are other presentations of amoxicillin that are more suitable for adults and other presentations more appropriate in some cases to the child (large doses, older children).

Dosage

In the subject with normal renal function

ADULT

The usual dosage is 1-1.5 or 2 g / day in 2 to 3 doses.

Special cases:

· Angina: 2 g / day in 2 daily doses.
The treatment duration of angina is 6 days.

· Acute pneumopathies: 3 g / day, ie 1 g every 8 hours,

· Lyme disease:

o strictly isolated chronic migrating erythema: 4 g / day.

o in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 6 g / day.

The duration of treatment will be 15 to 21 days.

· Endocarditis and septicemia (relay of the injectable route): the dosage can be increased up to 6 g per 24 hours in at least three doses.

· Prophylaxis of bacterial endocarditis:

o oral protocol: 3 g taken once a day, administered within one hour before the risky procedure,

o parenteral protocol relay: 1 g per os 6 hours after parenteral administration.

· Eradication of Helicobacter pylori in case of peptic ulcer disease: the following dosing regimens are recommended:

o amoxicillin 1 g morning and evening, combined with clarithromycin 500 mg morning and evening and omeprazole 20 mg morning and evening for 7 days, then 20 mg omeprazole daily for 3 additional weeks in case of progressive duodenal ulcer or 3 to 5 additional weeks in case of progressive gastric ulcer,
or

o amoxicillin 1 g morning and evening, combined with clarithromycin 500 mg morning and evening and lansoprazole 30 mg morning and evening, for 7 days, then 30 mg lansoprazole daily for 3 additional weeks in case of progressive duodenal ulcer or 3 to 5 additional weeks in case of progressive gastric ulcer.

The effectiveness of the treatment depends on compliance with the dosing regimen, including the taking of triple therapy during the first 7 days.

CHILD

· The usual dosage is as follows:

o for children under 30 months of age: 50 mg / kg / day at 100 mg / kg / day in 3 divided doses at 8 hours,

o for children older than 30 months: 25 mg / kg / day at 50 mg / kg / day in 2 or better 3 doses without exceeding the dosage of 3 g / day.

· In other infections, the recommended dosage is 80 to 100 mg / kg / day in 3 divided doses.

o acute otitis media
If a 72-hour probabilistic treatment and bacteriological documentation of a Streptococcus pneumoniae with decreased susceptibility to penicillin G fails, the recommended dosage is 150 mg / kg / day in 3 divided doses for 10 days. Up-to-date clinical data have shown bacterial eradication at this dose for S. pneumoniae strains with amoxicillin MIC ≤ 2 mg / l.

o Pneumonia.

· For more severe infections, as well as for endocarditis and septicemia (in relay of the injectable route): the dosage can be increased up to 150 mg / kg / day in 3 or 4 doses, without exceeding the dosage of 6 g /day.

Special cases:

· Angina: in children older than 30 months: 50 mg / kg / day, in 2 daily doses. The treatment duration of angina is 6 days.

· Lyme disease:

o chronic migrant erythema strictly isolated: 50 mg / kg / day,

o in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 100 mg / kg / day without exceeding 6 g / day.

The duration of treatment will be 15 to 21 days.

· Prophylaxis of bacterial endocarditis:

o Oral protocol: 75 mg / kg once taken, administered within one hour before the risky procedure;

o parenteral protocol relay: 25 mg / kg orally 6 hours after parenteral administration.

In patients with renal insufficiency

Administer a first loading dose (Do) equivalent to the dose normally prescribed and, depending on the degree of severity of the pathology:

Clearance of creatinine

Dosage scheme

greater than 30 ml / min.

No adaptation: continue treatment with usual dose and recommended frequency

from 10 to 30 ml / min.

Do / 2, every 12 hours

less than 10 ml / min.

Do / 2, every 24 hours

Hemodialysis: Do then Do / 2 a day. On days of dialysis, administer Do / 2 after the dialysis session.

Administration mode

ORAL WAY.

This medicine can be taken during or between meals.

Use the measuring spoon provided with the bottle.

Against indications

This medicine MUST NEVER BE USED in case of allergy to antibiotics of the beta-lactam family (penicillins and cephalosporins) or to any of the other ingredients;

This medicine SHOULD NOT BE USED in combination with methotrexate (see rurbic interactions with other drugs and other forms of interaction ).

Due to the presence of aspartame (8.5 mg per measuring spoon), this drug is contraindicated in cases of phenylketonuria.

Adverse effects Amoxicillin Qualimed

The classification of adverse reactions used is as follows:

· Very common: ≥1 / 10

· Frequent: ≥1 / 100; <1/10

· Uncommon: ≥1 / 1000; <1/100

· Rare: ≥1 / 10000; <1/1000

· Very rare: <1/10000

· Frequency not known: can not be estimated on the basis of available data

Blood and lymphatic system disorders

Very rare: leukopenia, neutropenia, agranulocytosis, thrombocytopenia and reversible haemolytic anemia.

Not known: eosinophilia.

Nervous system disorders

Very rare: convulsions.

Not known: vertigo, headache.

Gastrointestinal disorders

Common: diarrhea, nausea

Uncommon: vomiting.

Very rare: pseudomembranous colitis, hemorrhagic colitis.

Not known: superficial tooth staining in children, usually reversible after brushing teeth.

Renal and urinary disorders

Not known: acute interstitial nephritis and crystalluria.

Skin and subcutaneous tissue disorders

Common: rash

Uncommon: urticaria and pruritus.

Very rare: erythema multiforme, Stevens Johnson syndrome, Lyell syndrome, bullous or exfoliative dermatitis. These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or evolving lymphoid leukemia. Acute generalized exanthematous pustulosis (see Warnings and precautions for use ).

Infections and infestations

Common: cutaneous and mucosal candidiasis

Immune system disorders

Very rare: anaphylaxis (including anaphylactic shock), serum sickness and hypersensitivity vasculitis (see Warnings and precautions for use section ).

Not known: allergic manifestations, including urticaria, angioedema, respiratory discomfort.

Hepatobiliary disorders

Very rare: hepatitis, cholestatic jaundice.

Not known: moderate and transient increase in serum transaminases (ALT and / or ASAT).

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